Regulatory Text
21 C.F.R. § 310.4 — Biologics; products subject to license control.
§ 310.4 Biologics; products subject to license control. (a) If a drug has an approved license under section 351 of the Public Health Service Act (42 U.S.C. 262 et seq. ) or under the animal virus, serum, and toxin law of March 4, 1913 (21 U.S.C. 151 et seq. ), it is not required to have an approved application under section 505 of the act. (b) To obtain marketing approval for radioactive biological products for human use, as defined in § 600.3(ee) of this chapter, manufacturers must comply with the provisions of § 601.2(a) of this chapter. [64 FR 56448, Oct. 20, 1999, as amended at 70 FR 14981, Mar. 24, 2005]
Source: ecfr.gov · govinfo.gov — public domain
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Citation
21 C.F.R. § 310.4
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The regulatory text of 21 C.F.R. § 310.4 is reproduced from the official Code of Federal Regulations as published by the Office of the Federal Register and the National Archives and Records Administration.
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Title 21 — Food and Drugs
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